PDF(Pubmed)
Abstract：
UNASSIGNED: Roflumilast is effective in reducing acute exacerbation in patients with chronic obstructive pulmonary disease (COPD) at high risk of severe exacerbation. Clinical traits related to the benefits of roflumilast need to be evaluated in patients with COPD.
UNASSIGNED: A longitudinal observational study in patients newly diagnosed with COPD was conducted using claims data from the Health Insurance Review and Assessment Service in South Korea from 2012-2020 after a 2-year washout period. The primary outcome was to estimate the ratio of hazard ratio (RHR) of roflumilast for moderate-to-severe exacerbation in prespecified subgroups. A time-dependent Cox regression model was used to estimate the hazard ratio (HR) for moderate-to-severe exacerbations.
UNASSIGNED: Among 823,862 patients with COPD, 0.6% used roflumilast. The adjusted HR of roflumilast for moderate-to-severe exacerbations was reduced when treated for ≥3 months (RHR =0.558). Interaction effects of the variables on the HR of roflumilast for moderate-to-severe exacerbation were identified. The adjusted HR of roflumilast for moderate-to-severe exacerbation was significantly reduced in several subgroups: older age (65 years > age ≥50 years, RHR =0.838; age ≥65 years, RHR =0.818), a higher Charlson comorbidity index (1, RHR =0.832; 2, RHR =0.798; ≥3, RHR =0.790), history of exacerbation (RHR =0.886), bronchiectasis (RHR =0.774), chronic bronchitis (RHR =0.793), inhaled therapy [mono-bronchodilator, RHR =0.824; inhaled corticosteroid (ICS)/long-acting beta-agonist (LABA), RHR =0.591; LABA/long-acting muscarinic antagonist (LAMA), RHR =0.822; ICS/LABA/LAMA, RHR =0.570], methylxanthine (RHR =0.853), and statin (RHR =0.888).
UNASSIGNED: The benefit of roflumilast in moderate-to-severe exacerbations was estimated to be greater in specific subgroups of patients with COPD. Personalised approaches to roflumilast based on clinical phenotypes would be effective for COPD.
UNASSIGNED: A longitudinal observational study in patients newly diagnosed with COPD was conducted using claims data from the Health Insurance Review and Assessment Service in South Korea from 2012-2020 after a 2-year washout period. The primary outcome was to estimate the ratio of hazard ratio (RHR) of roflumilast for moderate-to-severe exacerbation in prespecified subgroups. A time-dependent Cox regression model was used to estimate the hazard ratio (HR) for moderate-to-severe exacerbations.
UNASSIGNED: Among 823,862 patients with COPD, 0.6% used roflumilast. The adjusted HR of roflumilast for moderate-to-severe exacerbations was reduced when treated for ≥3 months (RHR =0.558). Interaction effects of the variables on the HR of roflumilast for moderate-to-severe exacerbation were identified. The adjusted HR of roflumilast for moderate-to-severe exacerbation was significantly reduced in several subgroups: older age (65 years > age ≥50 years, RHR =0.838; age ≥65 years, RHR =0.818), a higher Charlson comorbidity index (1, RHR =0.832; 2, RHR =0.798; ≥3, RHR =0.790), history of exacerbation (RHR =0.886), bronchiectasis (RHR =0.774), chronic bronchitis (RHR =0.793), inhaled therapy [mono-bronchodilator, RHR =0.824; inhaled corticosteroid (ICS)/long-acting beta-agonist (LABA), RHR =0.591; LABA/long-acting muscarinic antagonist (LAMA), RHR =0.822; ICS/LABA/LAMA, RHR =0.570], methylxanthine (RHR =0.853), and statin (RHR =0.888).
UNASSIGNED: The benefit of roflumilast in moderate-to-severe exacerbations was estimated to be greater in specific subgroups of patients with COPD. Personalised approaches to roflumilast based on clinical phenotypes would be effective for COPD.
摘要：
■罗氟司特可有效减少慢性阻塞性肺疾病（COPD）严重加重风险高的患者的急性加重。需要在COPD患者中评估与罗氟司特益处相关的临床特征。
使用韩国健康保险审查和评估服务机构2012-2020年的索赔数据，对新诊断为COPD的患者进行了一项纵向观察性研究。主要结果是估计预定亚组中重度加重的风险比（RHR）。使用时间依赖性Cox回归模型来估计中度至重度加重的风险比（HR）。
■在823,862例COPD患者中，0.6%使用罗氟司特。当治疗≥3个月时，罗氟司特用于中重度加重的校正HR降低（RHR=0.558）。确定了变量对罗氟司特中度至重度加重的HR的交互作用。在几个亚组中，罗氟司特用于中度至重度加重的校正HR显着降低：年龄较大（65岁>年龄≥50岁，RHR=0.838；年龄≥65岁，RHR=0.818),较高的Charlson合并症指数（1，RHR=0.832；2，RHR=0.798；≥3，RHR=0.790），恶化史（RHR=0.886），支气管扩张（RHR=0.774），慢性支气管炎（RHR=0.793），吸入疗法[单支气管扩张剂，RHR=0.824；吸入皮质类固醇（ICS）/长效β-激动剂（LABA），RHR=0.591；LABA/长效毒蕈碱拮抗剂（LAMA），RHR=0.822；ICS/LABA/LAMA，RHR=0.570],甲基黄嘌呤（RHR=0.853），和他汀类药物（RHR=0.888）。
■在COPD患者的特定亚组中，罗氟司特对中度至重度加重的益处估计更大。基于临床表型的罗氟司特个性化方法对COPD有效。
使用韩国健康保险审查和评估服务机构2012-2020年的索赔数据，对新诊断为COPD的患者进行了一项纵向观察性研究。主要结果是估计预定亚组中重度加重的风险比（RHR）。使用时间依赖性Cox回归模型来估计中度至重度加重的风险比（HR）。
■在823,862例COPD患者中，0.6%使用罗氟司特。当治疗≥3个月时，罗氟司特用于中重度加重的校正HR降低（RHR=0.558）。确定了变量对罗氟司特中度至重度加重的HR的交互作用。在几个亚组中，罗氟司特用于中度至重度加重的校正HR显着降低：年龄较大（65岁>年龄≥50岁，RHR=0.838；年龄≥65岁，RHR=0.818),较高的Charlson合并症指数（1，RHR=0.832；2，RHR=0.798；≥3，RHR=0.790），恶化史（RHR=0.886），支气管扩张（RHR=0.774），慢性支气管炎（RHR=0.793），吸入疗法[单支气管扩张剂，RHR=0.824；吸入皮质类固醇（ICS）/长效β-激动剂（LABA），RHR=0.591；LABA/长效毒蕈碱拮抗剂（LAMA），RHR=0.822；ICS/LABA/LAMA，RHR=0.570],甲基黄嘌呤（RHR=0.853），和他汀类药物（RHR=0.888）。
■在COPD患者的特定亚组中，罗氟司特对中度至重度加重的益处估计更大。基于临床表型的罗氟司特个性化方法对COPD有效。
